MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS MRI; ANESTHESIA UNITS

Model Number	8607300
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fabius had a ventilator failure, no patient injury reported.
Additional Manufacturer Narrative
The log file was available for investigation.On the reported date of event, september 9th 2024 the reported ventilator failure could be confirmed.It was found that the airway pressure was more than 10mbar above the pmax limit adjusted by the user.In consequence a switch off of piston and pump was initiated for 200ms.If nevertheless the condition of a high airway pressure persists or returns within 2 seconds automatic ventilation is stopped as a safety measure.A corresponding "ventilator fail !!! alarm is posted.In case the airway pressure recovers, the device continues automatic ventilation without further interaction needed.As the issue could not be reproduced during on-site inspection and no hint for a device malfunction was found, it can be assumed that an external impact is likely, e.G.Patient coughing or repositioning of patient.In case automatic ventilation is shut down, manual ventilation and monitoring functions remain available.The number of similar cases, related to the same root cause.

• Brand Name: FABIUS MRI
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 20426235
• Report Number: 9611500-2024-00435
• Device Sequence Number: 8506433
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)190923(93)8607300-47
• Combination Product (Y/N): N
• PMA/510(K) Number: K072884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8607300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown